Zapalign Inc. (foreign exporter, Anyang-si Gyeonggi, KR): 20 new FDA device listings, incl. agent, tooth bonding, resin
Zapalign Inc. (Anyang-si Gyeonggi): 20 new FDA device listings, incl. agent, tooth bonding, resin. Its amount of 20 is top-decile (97th percentile of 2,570 records). Dated 49 days ago, it serves as a historical benchmark. Score 55/100. As of 2026-10-28, from openFDA device registration and listing endpoint (U.S. Food and Drug Administration).
Data as of · Compiled by Zalwin from openFDA device registration and listing endpoint (U.S. Food and Drug Administration)
amount: 20 · 97th percentile of 2,570 DeviceEstablishmentPulse records · 20.0x the median
Free preview: all 14 published fields of this record are shown below. Locked: 116 related KR DeviceEstablishmentPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Establishment | Zapalign Inc. |
| Role | Foreign exporter |
| Establishment types | Export Device to the United States But Perform No Other Operation on Device |
| Location | Anyang-si Gyeonggi, KR |
| New listings | 20 |
| Devices | Agent, Tooth Bonding, Resin; Material, Impression; Cement, Dental; Material, Tooth Shade, Resin; Crown And Bridge, Temporary, Resin; Bur, Surgical, General & Plastic Surgery; System, Skin Closure; Sealant, Pit And Fissure, And Conditioner; Zinc Oxide Eugenol; Set, Administration, Intravascular |
| Product codes | KLE, ELW, EMA, EBF, EBG, GFF, MKY, EBC, EMB, FPA, ELZ |
| Device classes | Class I, Class II |
| Medical specialties | Dental, General, Plastic Surgery, General Hospital |
| Brand names | AGENT, TOOTH BONDING, RESIN; MATERIAL, IMPRESSION; CEMENT, DENTAL; Material, tooth shade, resin; CROWN AND BRIDGE, TEMPORARY, RESIN; BUR, SURGICAL, GENERAL & PLASTIC SURGERY; SYSTEM, SKIN CLOSURE; ZINC OXIDE EUGENOL |
| First new listing | 2026-05-04 |
| Latest new listing | 2026-09-16 |
| FDA registration number | 3011944170 |
| Registration expires | 2026-12-31 |
| amount percentile | 97th of 2,570 (median 1, 20.0x median) |
| Peer records CSV (117 KR records) | 🔒 Click to unlock → |
| CRM-ready export with official source URLs | 🔒 Click to unlock → |
Watch Zapalign Inc.
Free email alert. Alert me when this company gets a new filing, lien, permit, contract or expiry in this feed. One confirmation email; unsubscribe any time.
Free for 1 company. More companies from $9/mo (25), $49/mo (500 + CSV), $199/mo (500 + CSV + API). Cancel any time from the link in every email.
Free first: a 10-record sample of KR records
See the real columns before you buy. One confirmation email, nothing else unless you opt in.
Unlock Zapalign + all 117 KR records (CSV)
Instant CSV download · Card, Apple Pay, Google Pay or Link via Stripe · No account required
CSV columns: Establishment · Role · New listings · Devices · Latest listing · official source URL
- Source agency: openFDA device registration and listing endpoint (U.S. Food and Drug Administration)
- Record date: 2026-09-16
- Data refreshed: 2026-10-28
- Refunds on request within 14 days
Top DeviceEstablishmentPulse records (KR first): Samsung Medison Co., Ltd. (manufacturer, Gumi-si Gyeongbuk, · Samsung Medison Co., Ltd. (manufacturer, HONGCHEON-GUN Gangw · Osstem Implant Co.,Ltd. (manufacturer, Yeonsu-gu Incheon, KR · Boditech Med Inc. (manufacturer, Chuncheon Gangwon, KR) · Zimmer Biomet Korea Ltd. (foreign exporter, Seoul, KR) · Browse all by state and category →
LIVE PUBLIC DATA Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration) · Last refreshed: Wed, 28 Oct 2026 20:51:27 GMT
Is this your business? Add a "Listed on Zalwin" badge to your site
Paste this snippet into your website. It links to this public record; nothing is tracked on your site.
Peer benchmark and outreach value: Zapalign Inc. and 117 KR peers
- KR DeviceEstablishmentPulse records like this one: 117
- Zapalign Inc.'s amount: 97th percentile of 2,570 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every KR peer: $23,400 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
55 / 100 Score
- Class II or III devices: QMS and regulatory demands.
- Several new listings at once.
What is the DeviceEstablishmentPulse record for Zapalign Inc. in Anyang-si Gyeonggi?
Zapalign Inc. (Anyang-si Gyeonggi, KR), a foreign exporter, added 20 FDA device listings between 2026-05-04 and 2026-09-16.
How does Zapalign Inc. compare to other DeviceEstablishmentPulse records?
This is a top-decile record: its amount of 20 is 20.0x the median of 1 across 2,570 records. It is 49 days old; check the official source for later updates before acting.
Zapalign Inc. vs. top 3 peers
| Organization | Location | Amount | Percentile | Record date |
|---|---|---|---|---|
| Zapalign Inc. | Anyang-si Gyeonggi, KR | 20 | 97th | 2026-09-16 |
| Makar Consulting PTY Ltd | Belrose New South Wales, AU | 21 | 97th | 2026-10-16 |
| Tam Viet Distribution Company Limited | Ho Chi Minh, VN | 17 | 96th | 2026-10-16 |
| Kash Sales Inc. | Richmond Hill Ontario, CA | 15 | 96th | 2026-10-16 |
Related records
- Mka Medikal Ic Ve Dis Ticaret Sanayi Limited Sirketi
- Worldwide Supplies Limited
- Kash Sales Inc.
- Makar Consulting PTY Ltd
- Tam Viet Distribution Company Limited
- Can Technomed Trading Ltd.
- Innopex Limited
- Cbr Enterprise Limited
- Ad Supply Group Limited
- Optikal (Southgate) Ltd
- Soher Med Limited
- Loudwater Trade Finance Ltd
DeviceEstablishmentPulse: Foreign exporter DeviceEstablishmentPulse: Foreign establishment
How to monitor Zapalign Inc. and peer foreign exporter records
Get new DeviceEstablishmentPulse records like Zapalign Inc. by email (free, weekly)
We email one confirmation link now; the weekly digest starts only after you confirm. One-click unsubscribe in every email.
Double opt-in: nothing is sent until you click the confirmation link. One-click unsubscribe.
Get new device listings in your specialties
DeviceEstablishmentPulse emails device establishments with new FDA listings matching your roles and states.
✓ Read-only, live public data · Key and unlock right after payment · Card, Apple Pay, Google Pay or Link via Stripe · Refunds on request within 14 days
From the openFDA device registration and listing data, refreshed weekly. A listing shows a device an establishment says it makes or handles for the U.S. market; it is not FDA clearance or approval. Contact persons and street addresses are not stored. Verify in the FDA Establishment Registration and Device Listing database.